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The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of BIIB037 after single-dose administration.
BIIB037 is an investigational product being developed as a treatment for Alzheimer's disease (AD). BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is selective for the fibrillar form of beta amyloid (Aß).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB037 | Experimental | A single dose of BIIB037 by intravenous infusion. |
|
| Placebo | Placebo Comparator | A single dose of placebo matching BIIB037 by intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB037 | Drug | Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), and brain MRI findings (including the occurrence of vasogenic edema and incident hemorrhage). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞] | 6 months | |
| Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast] | 6 months | |
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Key Inclusion Criteria:
Must be ambulatory
Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the following:
Subject (or subject's permanent caregiver) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or assent) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
Must have a Mini Mental State Examination (MMSE) score of 14 to 26 inclusive.
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Matters Research | Delray Beach | Florida | 33445 | United States | ||
| Compass Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29067304 | Derived | Ferrero J, Williams L, Stella H, Leitermann K, Mikulskis A, O'Gorman J, Sevigny J. First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2016 Jun 20;2(3):169-176. doi: 10.1016/j.trci.2016.06.002. eCollection 2016 Sep. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000600266 | aducanumab |
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|
| Placebo | Other | Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion. |
|
| Maximum Concentration [Cmax] of BIIB037 |
| 6 Months |
| Time to Cmax [Tmax] | 6 Months |
| Elimination Half-life [t1/2] | 6 Months |
| Clearance [Cl] | 6 Months |
| Incidence of Anti-BIIB037 Antibodies in Serum | 6 Months |
| Orlando |
| Florida |
| 32806 |
| United States |
| Insight Clinical Trials, LLC | Beachwood | Ohio | 44122 | United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |